An interventional study of standard enteral nutrition and high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan in Critical Illness, sponsored by Yonsei University. Completed. Per ClinicalTrials.gov, last updated 2015-10-06.
Sponsored by Yonsei University · Not applicable and Interventional
To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients.
To determine whether high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients (eg, ω-3 fatty acids and antioxidants) enriched with β-glucan stimulates immune functions compared with standard enteral nutrition (control: 20% of total calorie from protein) or high-protein (24% of total calorie from protein) enteral nutrition of immune modulating nutrients without β-glucan in critically ill patients. In a randomized double-blind placebo-controlled study, 30 patients consumed 1 of 3 enteral nutrition: control, enteral nutrition of immune modulating nutrients enriched with β-glucan (250mg/L) or enteral nutrition of immune modulating nutrients without β-glucan. Enteral nutrition was initiated within 24 hours of ICU admission and continued during the ICU stay for a 7 days.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 30 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
standard enteral nutrition
Dietary Supplement: standard enteral nutrition
high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
high-protein enteral nutrition of immune modulating nutrients without β-glucan
Dietary Supplement: high-protein enteral nutrition of immune modulating nutrients without β-glucan
standard enteral nutrition
Also known as: control group
high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
Also known as: test group I
high-protein enteral nutrition of immune modulating nutrients without β-glucan
Also known as: test group II
Change from baseline NK cell activity at 7 days
NK cell activity (%)
Time frame: at baseline and 7 days follow-up
Change from baseline IL-12 at 7 days
IL-12 (pg/mL)
Time frame: at baseline and 7 days follow-up
Change from baseline hs-CRP at 7 days
hs-CRP (mg/dL)
Time frame: at baseline and 7 days follow-up
No study locations are listed for this record.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Yonsei University